ABIOMED Impella CP Smart Assist Set: recall status

Notice names this product. Abiomed’s ABIOMED Impella CP Smart Assist Set is named in FDA Class I recall Z-2690-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. Identifying details: Pump Set Code 0048-0024-JP; Introducer Product Code 0052-3025-JP. GTIN: 00813502011609. All current batches in field.. Units affected: 8,382 units. Status: Ongoing.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: ABIOMED Impella CP Smart Assist Set
Company / brand: Abiomed
Lot / serial / date codes: Pump Set Code 0048-0024-JP; Introducer Product Code 0052-3025-JP. GTIN: 00813502011609. All current batches in field.
Distribution: Worldwide distribution. US Nationwide, Australia (AU), Austria (AT), Belgium (BE), Brazil (BR), Brunei (BN), Canada (CA), China (CN), Croatia (HR), Czech Republic (CZ), Denmark (DK), Finland (FI), France (FR), Germany (DE), Greece (GR), Hong Kong (HK), Ireland (IE), Israel (IL), Italy (IT), Japan (JP), Kuwait (KW), Luxembourg (LU), Malaysia (MY), Mexico (MX), Netherlands (NL), Norway (NO), Panama (PA), Poland (PL), Saudi Arabia (SA), Serbia (RS), Slovenia (SI), South Korea (KR), Spain (ES), Sweden (SE), Switzerland (CH), Taiwan (TW), Thailand (TH), United Arab Emirates (AE), and United Kingdom (GB).

Agency product description and boundaries

ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

Brand: Abiomed

Recalls naming this model

FDA Class I · Medical device · July 22, 2026

ABIOMED Impella CP Smart Assist Set recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Company / brand: Abiomed recalls

Affected product: ABIOMED Impella CP Smart Assist Set recall status

Official ID Z-2690-2026 · Official record ↗

See all Abiomed recalls →

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.